In a previous blog post, we highlighted the essential role of surface characterization in ensuring the biocompatibility...
Within the last five years, there has been significant advancement in chemical analysis and toxicological risk assessment...
Within the last five years, there has been significant advancement in chemical analysis and toxicological risk assessment...
The European Union (EU) Medical Device Regulation 2017/745 (EU MDR) aims to ensure a high level of...
In the European Union (EU), a device is considered equivalent if it fulfills all the requirements of...
In the European Union (EU), the Medical Device Regulation (EU MDR) has replaced the Medical Device Directive...
The In Vitro Diagnostic Directive (EU) 98/79/EC (IVDD) was introduced over two decades ago to establish the...
Medical device manufacturers should always refer to ISO 10993 Series of Standards in addition to region-specific regulatory...
The FDA has recently published a Recommended Acceptable Limit guidance document for nitrosamine impurities in drug products....
Per- and poly-fluoroalkyl substances (PFAS) are a group of fluorinated compounds characterized by carbon-fluorine bonds. While some...
If you are keeping abreast of FDA’s medical device efforts, then you know that as of October...
The new version of ISO 10993-17 is expected to be published very soon. This is a major...
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